ADAC MODELS XL-PLAN 23 & XL-PLAN 73— 510(k) K851041

Substantially Equivalent

Adac Laboratories

FDA 510(k) clearance K851041 for ADAC MODELS XL-PLAN 23 & XL-PLAN 73, Substantially Equivalent on 1985-07-18. Applicant: Adac Laboratories.

Clearance details

Applicant: Adac Laboratories
Product code: Code IYE
Advisory panel: Radiology
Date received: 1985-03-14
Decision date: 1985-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.